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临床试验/NCT07675382
NCT07675382已完成不适用

Effects of an Eight-Week Whole-Body Electromyostimulation and Diet Program on Body Composition, Cardiometabolic Markers, and the Myokines Irisin and Betatrophin in Women With Obesity: A Randomized Controlled Trial

Firat University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Body Weight

研究概览

简要总结

This randomized controlled trial investigated the effects of an 8-week whole-body electromyostimulation (WB-EMS) combined with a hypocaloric diet on body composition, cardiometabolic markers, and serum levels of the myokines irisin and betatrophin (ANGPTL8) in women with obesity. Participants were randomly assigned to either a diet-only group or a diet plus WB-EMS group. WB-EMS sessions were conducted twice weekly (20-25 minutes per session) over 8 weeks. The primary outcomes included BMI, body fat percentage, lean body mass, fasting blood glucose, insulin, HOMA-IR, HbA1c, lipid profile, CRP, and serum irisin and betatrophin concentrations. The study aimed to evaluate whether WB-EMS adds metabolic and myokine-related benefits beyond those achieved by dietary restriction alone in obese women.

详细描述

This study was a randomized controlled trial (RCT) designed to investigate the effects of an 8-week whole-body electromyostimulation (WB-EMS) combined with a hypocaloric diet on body composition, cardiometabolic markers, and serum levels of the myokines irisin and betatrophin (ANGPTL8) in women with obesity.

Participants were randomly assigned to one of two groups: (1) Diet-only group (control): received a hypocaloric diet prescription without exercise training; (2) WB-EMS + Diet group (intervention): received the same hypocaloric diet plus WB-EMS training sessions conducted twice weekly (20-25 minutes per session) over 8 weeks.

Body composition assessments included body weight, BMI, body fat percentage, fat mass, fat-free mass, and waist circumference, measured using multifrequency bioelectrical impedance analysis (InBody 270). Cardiometabolic markers assessed included fasting blood glucose, serum insulin, HOMA-IR, HbA1c, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, blood pressure, and C-reactive protein (CRP). Serum irisin and betatrophin concentrations were measured at baseline and post-intervention using ELISA.

The primary aim was to evaluate whether WB-EMS combined with dietary restriction provides additional metabolic and myokine-related benefits beyond those achieved by dietary restriction alone in obese women.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult women aged 18-65 years
  • BMI >= 30 kg/m2 (obesity)
  • Sedentary lifestyle (no regular physical activity for the past 6 months)
  • Willingness to participate and provide written informed consent

排除标准

  • Pregnancy or breastfeeding
  • Cardiovascular disease, neurological disorders, or implanted pacemaker/defibrillator
  • Active cancer or ongoing chemotherapy/radiotherapy
  • Use of medications affecting body weight or metabolic parameters
  • Prior WB-EMS training experience
  • Skin conditions contraindicating electrode use

结局指标

主要结局

Body Weight

时间窗: 8 weeks (baseline to post-intervention)

Changes in body weight (kg) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).

Body Mass Index (BMI)

时间窗: 8 weeks (baseline to post-intervention)

Changes in body mass index (BMI, kg/m²) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).

Body Fat Percentage

时间窗: 8 weeks (baseline to post-intervention)

Changes in body fat percentage (%) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).

Fat Mass

时间窗: 8 weeks (baseline to post-intervention)

Changes in fat mass (kg) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).

Fat-Free Mass (Lean Body Mass)

时间窗: 8 weeks (baseline to post-intervention)

Changes in fat-free mass / lean body mass (kg) measured by multifrequency bioelectrical impedance analyser (InBody 270) from baseline to post-intervention (8 weeks).

Waist Circumference

时间窗: 8 weeks (baseline to post-intervention)

Changes in waist circumference (cm) measured by standard anthropometric tape from baseline to post-intervention (8 weeks).

次要结局

  • Fasting Blood Glucose (FBG)(8 weeks (baseline to post-intervention))
  • Serum Insulin(8 weeks (baseline to post-intervention))
  • HOMA-IR (Insulin Resistance)(8 weeks (baseline to post-intervention))
  • Glycated Haemoglobin (HbA1c)(8 weeks (baseline to post-intervention))
  • Total Cholesterol (TC)(8 weeks (baseline to post-intervention))
  • Triglycerides (TG)(8 weeks (baseline to post-intervention))
  • LDL Cholesterol (LDL-C)(8 weeks (baseline to post-intervention))
  • HDL Cholesterol (HDL-C)(8 weeks (baseline to post-intervention))
  • C-Reactive Protein (CRP)(8 weeks (baseline to post-intervention))
  • Serum Irisin(8 weeks (baseline to post-intervention))
  • Serum Betatrophin (ANGPTL8)(8 weeks (baseline to post-intervention))
  • Systolic Blood Pressure(8 weeks (baseline to post-intervention))
  • Diastolic Blood Pressure(8 weeks (baseline to post-intervention))

研究者

发起方
Firat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Murat Açık

Assistant Professor

Firat University

研究点 (1)

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